Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

Akros Pharma

Status and phase: Terminated; Phase 2

Conditions: Type II Diabetes Mellitus

Treatments: Drug: JTT-654; Drug: JTT-654 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00997152

AT654-U-09-004

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.

Enrollment: 152 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have type 2 diabetes;
2. Body mass index (BMI) of ≤ 45.0 kg/m2;
3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion criteria

1. Females who are pregnant or breast-feeding;
2. Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 3 patient groups, including a placebo group

Dose 1 JTT-654

Experimental group

Treatment:

Drug: JTT-654

Dose 2 JTT-654

Experimental group

Treatment:

Drug: JTT-654

Placebo

Placebo Comparator group

Treatment:

Drug: JTT-654 Placebo